BD Pyxis recallZ-0906-2025 · CareFusion 303, Inc. · initiated Apr 5, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CareFusion 303, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order, the order may display as grayed out; alternate location tooltip will display "Server connection failed," not listing other area devices where unavailable item(s) may be found, which may lead to delayed therapy.
FDA root cause category: Software design
What the company is doing
On 4/5/2023, correction notices were sent to customers who were asked to do the following: A permission-based feature called "Global Find" can be used to obtain alternate storage locations of medication(s) not loaded (by pharmacy) or depleted at that device and is not impacted by this issue. 1) Review and confirm that backup procedures (which may include but may not necessarily be limited to keys, emergency medication supplies, alternate devices in proximity, etc.) are in place and staff have all been properly trained on them to avoid delays in access to medications. 2) Ensure this letter is forwarded to applicable facilities if devices have been transferred and that all appropriate personnel have been made aware of this issue. 3) Complete and return the enclosed Customer Response Form via email to [email protected] 4) Adverse health consequences experienced with the use of this product should be reported to BD at 1-800-727-6102 or via bd.com/self-service. Recall/Letter Questions: BD Customer Support, Phone: 1-866-583-8783, Phone Hours: 5:00am PST to 4:00pm PST (8:00am ET to 7:00pm ET), Monday - Friday A software update is available. BD will contact you to schedule a time to install the software update.
Recall details
- Recall number
- Z-0906-2025
- Status
- Open, Classified
- Initiated by the company
- Apr 5, 2023
- Posted by the FDA
- Jan 14, 2025
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 622
- Product code
- BRY
- Distribution
- US Nationwide distribution in the states of NY, NC, LA.
Product description
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Code information (models, lots, serial numbers)
Software v1.7.3. REF/UDI-DI: 323/10885403512667, 352/10885403512674
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- BD Pyxis 323Carefusion 303, Inc. · CABINET, TABLE AND TRAY, ANESTHESIA14 recalls2 deaths24,375 reports
- BD Pyxis 352Carefusion 303, Inc. · CABINET, TABLE AND TRAY, ANESTHESIA12 recalls898 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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